MAUDE Adverse Event Report: DBMEDX INC. BBS REVOLUTION¿; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	PD-010-0002
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was bladder scanned by na [nurse assistant] [redacted] at approximately 1704 for 568cc.Rn performed straight catheterization per order at approximately 1830 for 1200cc without complication.Note: we have had continued issues with this device.Bd has come in and trained our staff on the proper way to use the bladder scanner, but staff continue to find this device difficult to use even when instructions are followed meticulously.

• Brand Name: BBS REVOLUTION¿
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): DBMEDX INC.; 10394 w chatfield ave.; suite 109; littleton CO 80127
• MDR Report Key: 24277861
• Report Number: 24277861
• Device Sequence Number: 20105093
• Product Code: ITX
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2026
• Report Date (Section F): 01/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: PD-010-0002
• Device Catalogue Number: PD-010-0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/27/2026